Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.

Device Description

Thixo-Gel Ultrasound Spray® is a colorless, thisotropic gel contained in a dispenser that allows it to be dispersed as a thin layer on external, intact skin.

AI/ML Overview

Acceptance Criteria and Study for Thixo-Gel Ultrasound Spray®

This device, Thixo-Gel Ultrasound Spray®, is classified as a Diagnostic Ultrasound Transducer Accessory. The FDA has not established special controls or performance standards for this device. Therefore, the acceptance criteria are primarily based on demonstrating substantial equivalence to a predicate device (Aquasonic 100®) through comparison of technological characteristics and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Top Testing)	Reported Device Performance (Thixo-Gel Ultrasound Spray®)
Biocompatibility (in accordance with ISO-10993)	Safe as Predicate Device, passed ISO-10993 testing
Bacterial contamination (shelf life retests)	Performed, results not explicitly detailed but implied compliance
Physical property comparison to predicate (Acoustic Impedance, Density, Attenuation @ 10 MHz, Sound Velocity)	Substantially equivalent (values provided below)
Same Intended Use as predicate device	Substantially equivalent

Detailed Physical Property Comparison:

Feature	Thixo-Gel Ultrasound Spray® (Reported Performance)	Aquasonic 100® (Predicate)	Acceptance Criteria Met?
Acoustic Impedance	0.166 gm/cm²	0.163 gm/cm²	Yes
Density	1056 km/m³	1012 km/m³	Yes
Attenuation @ 10 MHz	1-2 dB/mm	1-2 dB/mm	Yes
Sound Velocity	1566 m/sec	1588 m/sec	Yes
Device Description (Couplant)	Ultrasound Couplant	Ultrasound Couplant	Yes
Dispenser	250 ml nozzle spray bottle (single use)	250 ml squeeze bottle (refillable)	Considered substantially equivalent despite difference in dispenser type/refillability due to functional equivalence as a coupling medium.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a distinct "test set" in the context of clinical trials or human subject testing for this device. The evaluation primarily relies on bench-top testing and comparison to the predicate device.

For Biocompatibility: Tests were performed in accordance with ISO-10993. The sample size for biocompatibility testing (e.g., number of samples tested for cytotoxicity, sensitization, irritation) is not explicitly stated but is implicitly governed by the ISO-10993 standard.
For Bacterial Contamination: Retests were performed for shelf life. The sample size is not explicitly stated.
For Physical Property Comparison: The values provided (Acoustic Impedance, Density, etc.) are intrinsic properties of the material. The sample size would refer to the number of batches or samples evaluated to ensure these properties are consistent. This information is not detailed in the summary.
Data Provenance: The origin of the data is from bench-top laboratory tests conducted by the submitter (Cloverline International Pharma Services GmbH). Both the biocompatibility and physical property comparison tests are inherently retrospective in the sense that they are conducted on manufactured samples to characterize the device properties.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of device and study. The ground truth for this device (an ultrasound coupling medium) is established through standardized laboratory testing and material characterization, not expert clinical interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical imagery or diagnostic output requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is an ultrasound coupling medium, not an AI-assisted diagnostic tool. Its performance is evaluated based on its physical properties and biocompatibility, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical product (ultrasound gel), not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

Standardized Laboratory Measurements: For physical properties like acoustic impedance, density, attenuation, and sound velocity, using appropriate laboratory equipment and methods.
International Standards Compliance: For biocompatibility, adherence to ISO-10993 standards constitutes the ground truth for safety in biological interaction.
Predicate Device Data: The physical properties of the predicate device (Aquasonic 100®) serve as a comparative ground truth for demonstrating substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is furnished in accordance with requirements detailed in 21 CFR 807.92.

The assigned 510(k) number is K-121311

Submitter's Identification: Cloverline International Pharma Services GmbH Teinacher Strasse 49 Ludwigsburg, Germany D-71634 Correspondence:

Christina Bernstein BB Medical Surgical, inc. 2670 Leavenworth Street San Francisco, CA 94133. Tel: 415-450-0515 Email tina@bbmedicalsurgical.com

Date of submission 25 April 2012 Date of revised summary 31 July 2012, second revision 15 August 2012.

Device name:

Proprietary name: Thixo-Gel Ultrasound Spray®

A.Regulation Section: 21 CFR 892-1570 Diagnostic Ultrasound Transducer Accessory

B.Classification: Class II

C.Product Code: MUI

D.Panel: Radiology

Intended Use:

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Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.

Device Description:

Thixo-Gel Ultrasound Spray® is a colorless, thisotropic gel contained in a dispenser that allows it to be dispersed as a thin layer on external, intact skin.

Summary 15 August Thixo-gel page 1

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Substantial Equivalence Information:

A. Predicate device name: Aquasonic 100®
- B. Predicate device K number: 802146
- C. Comparison with predicate:

SUBSTANTIALEQUIVALENCE TABLE	THIXO-GELULTRASOUND SPRAY ®	AQUASONIC 100 ®
K-Number	121311	802146
Device Description	UltrasoundCouplant	UltrasoundCouplant
Acoustic Impedance	0.166 gm/cm2	0.163 gm/cm2
Density	1056 km/m3	1012 km/m3
Attenuation @ 10 MHz	1-2 dB/mm	1-2 dB/mm
Sound Velocity	1566 m/sec	1588 m/sec
Dispenser	250 ml nozzlespray bottle(single use)	250 ml squeeze.bottle(refillable)

6.

Test Principle, Performance Characteristics:

FDA has not established special controls or performance standards for this device.

Bench Top Testing:

Tests for biocompatibility were performed in accordance with ISO-10993. ^

Bacterial contamination retests were also performed on the subject device for shelf life

1 201 2007 :

Physical property comparison tests were performed on the submitted device and predicate. Comparison
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onclusions:

Thixo-Gel Ultrasound Spray® is similar in intended use and technological characteristics to predicate devices reviewed used to couple ultrasound devices to skin. The device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.

Contraindications: Thixo-Gel Ultrasound Spray® is not:for use with defibrillators. Warnings and Precautions: The precautions are provided in the device labeling for Thixo-Gel Ultrasound Spray®. There is no warning associated with this lavine.

9.

Description	Comparison with Predicate Device
Biocompatibility	Safe as Predicate Device
Performance Characteristics	Substantially equivalent
Intended Use	Substantially equivalent
Performance Tests	Not Required

The device Thixo-Gel Ultrasound Spray®, based on the information submitted in this device 4 QUAACONIC 1980 TI 2015 Cranetially equivalent to the predicate device AQUASONIC 100® (K-802146), manufactured by Parker Laboratories Inc.

Summary 15 August Thixo-gel par

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AUG 3 0 2012

Cloverline International Pharma Services GmbH % Ms. Christina Bernstein US Agent BB Medical Surgical, Inc. 2670 Leavenworth Street SAN FRANCISCO CA 94133

Re: K121311

Trade/Device Name: Thixo-Gel Ultrasound Spray® Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: August 7, 2012 Received: August 7, 2012

Dear Ms. Bernstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occurity in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regally manetee profite Medical Device Amendments, or to commerce prior to May 20, 1977, the encordance with the provisions of the Federal Food, DNAA devices that have been recialsmod in acce approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, dicretore, market the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is Classificu (sec above) into enas ff (one device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Ood of I cannouncements your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation on a succession make a mains of the Act
that FDA has made a determination that your device complies . You must that FDA has made a determination and regulations administered by other Federal agencies. You must of any Federal statutes and regulations administered of on registration and listing (21).
comply with all the Act's requirements, including, but not limited to: registing of comply with all the Act 3 requirements, including, or medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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STO (K) APPLIC TION THING GEL UTITASQUAD SPRAY®

Indications for Use Form

510(k) Number (if known): K-121311

Device Name: Thixo-Gel Ultrasound Spray®

Indications for Use:

Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.

Over-The-Counter Use Prescription Use _ Yes AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kla1311

Page 1 of

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.